Strategic Objective 2.2: Protect individuals, families, and communities from infectious disease and non-communicable disease through equitable access to effective, innovative, readily available diagnostics, treatments, therapeutics, medical devices, and vaccines

HHS is working on strategies to protect the public from known and emerging infectious diseases and prevent non-communicable diseases, including cardiovascular diseases, cancer, diabetes, and other chronic conditions.  HHS advances the development and delivery of safe and effective, and innovative diagnostics, treatments, therapeutics, medical devices, and vaccines.  HHS invests in innovative technology and development to ensure the supply and availability of diagnostics, treatments, therapeutics, medical devices, and vaccines while leveraging resources and collaborations to support and apply research, evaluation, and data insights about non-communicable and infectious disease.

Objectives represent the changes, outcomes and impact the HHS Strategic Plan is trying to achieve.  This objective is informed by data and evidence, including the information below.

• Infectious diseases are a major cause of illness, disability, and death in the United States—and many are vaccine preventable.  Though infectious diseases are a public health threat for people of all ages and racial/ethnic groups, some populations are disproportionately affected.  The incidence of TB and hepatitis B, for example, is higher in the Asian population than other groups.  Hepatitis A rates have increased since 2014 in unvaccinated adults who experience homelessness or use drugs, and rates of hepatitis C have increased since 2013 in young people who inject drugs.  (Source: Immunization and Infectious Diseases Workgroup)
• In 2020, estimated global coverage with the third dose of diphtheria, tetanus, and pertussis-containing vaccine (DTP) and a polio vaccine decreased to 83 percent; coverage with the first dose of measles-containing vaccine decreased to 84 percent.  Globally, 17.1 million children did not receive the first DTP dose by age 12 months, an increase of 3.5 million from 2019.  (Source: Morbidity and Mortality Weekly Report (MMWR), Routine Vaccination Coverage)  In 2019, the United States had the highest number of measles cases since 1992—and since measles was declared eliminated in 2000.  (Source: Immunization and Infectious Diseases Workgroup)
• In 2018, nearly one in five Americans had a sexually transmitted infection (STI), with close to 68 million infections.  Almost half of new STIs were among youth from 15–24 yrs.  New STIs total $16 billion in direct medical costs.  (Source: Sexually Transmitted Diseases (STDs): At A Glance)
• Annually, at least 2.8 million Americans get an antibiotic-resistant infection, and more than 35,000 die.  The estimated national cost for treating antibiotic resistance is more than $4.6 billion annually.  (Source: Antibiotic Resistance Threats in the United States 2019)
• During the 2019–2020 influenza season, CDC estimates that influenza was associated with 38 million illnesses, 18 million medical visits, 405,000 hospitalizations, and 22,000 deaths.  (Source: 2019-2020 Flu Season Burden Estimates)  The influenza burden was higher in young children (0–4 years) and adults (18–49 years) compared with the 2017–2018 season, a recent season with high severity, and provides evidence to support how severe seasonal influenza can be at any age.  (Source: 2018-2019 Flu Season Burden Estimates)
• Noncommunicable diseases, also known as chronic diseases, such as heart disease, stroke, cancer, chronic respiratory disease, and diabetes, are the leading cause of death and disability worldwide.  (Source: Global Noncommunicable Diseases Fact Sheet)  Six in 10 adults in the United States have a chronic disease.  Four in 10 adults in the United States have two or more chronic diseases.  (Source: Chronic Disease in America)  Heart disease and cancer are the top two causes of death in the United States, accounting for 44.2 percent of all deaths in 2018.  (Source: Health, United States, 2019)  Four cancers—lung, breast, prostate, colorectal—account for almost half of all U.S. cancer deaths.  (Source: Healthy People 2030: Cancer Workgroup)  People who live in counties in the United States that experience persistent poverty are more likely to die from cancer than people in other counties.  (Source: Persistent Poverty Linked to Increased Risk of Dying from Cancer)
• In 2019 an estimated 229 million cases of malaria occurred worldwide and 409,000 people died.  About 2,000 cases of malaria are diagnosed in the United States each year.  (Source: Malaria)  Two U.S. Phase 1 clinical trials of a novel candidate malaria vaccine have found that the regimen conferred unprecedentedly high levels of durable protection when volunteers were later exposed to disease-causing malaria parasites.  A Phase 2 clinical trial of the vaccine is now underway in Mali, a malaria-endemic country.  If the approach proves successful there, chemoprophylaxis vaccination, or CVac, potentially could help reverse the stalled decline of global malaria.  Currently, there is no vaccine in widespread use for the mosquito-transmitted disease.  (Source: Investigational Malaria Vaccine Gives Strong, Lasting Protection)
• Countermeasures Acceleration Group, a partnership between HHS and the U.S. Department of Defense, accelerated the development of a COVID-19 vaccine.  The U.S. Government Accountability Office reviewed how vaccine companies combined some steps in the development process to meet unprecedented timeframes.  It noted the manufacturing challenges and efforts to address them.  For example, agencies worked to expedite procurement and delivery of equipment to address manufacturing challenges.  (Source: Coronavirus Oversight)
• Foodborne illness is common, costly, and preventable.  Foodborne hazards—including germs, undeclared allergens, and chemical contaminants—can enter the food supply at any point from farm to table.  Antibiotic-resistant foodborne infections cause more serious health outcomes and are more expensive to treat.  Each year, one in six Americans get sick from contaminated food.  Anyone can get a foodborne illness, but some groups are at greater risk for hospitalizations and death from these illnesses—for example, children younger than five years, people older than 65 years, pregnant women, and people with reduced immunity.  (Source: Healthy People 2030: Food Safety Workgroup)

Contributing OpDivs and StaffDivs

AHRQ, ASPR, CDC, CMS, FDA, HRSA, IHS, NIH, OASH, and OGA work to achieve this objective.

HHS OpDivs and StaffDivs engage and work with a broad range of partners and stakeholders to implement the strategies and achieve this Objective.  They include: the Antimicrobial Resistance/National Antimicrobial Resistance Monitoring System (NARMS), Board of Scientific Counselors, Deputy Director for Infectious Diseases, Healthcare Infection Control Practices Advisory Committee (HICPAC), Partnership for Food Protection (PFP), Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), Retail Food Flexible Funding Model Cooperative Agreement Program (CAP), Retail Food Safety Regulatory Association Collaborative, and State Produce Implementation Cooperative Agreement Program (CAP).

Strategies

Develop and deliver evidenced-based safe and effective, testing, treatments, therapeutics, medical devices, vaccines, and prevention strategies

• Mobilize resources and collaborations, including domestic, international, and public-private partnerships to support the research, development, testing, manufacture, and equitable distribution of safe and effective prevention strategies, diagnostics, vaccines, therapeutics, and medical devices for non-communicable and infectious disease.
• Increase collaboration with domestic and international partners, including community-based organizations, to improve confidence in vaccines and vaccination uptake rates, especially among disproportionately affected populations.
• Build and support sustainable immunization programs, and capacity at local, national, regional, and global levels to better prevent and respond to disease-specific challenges and meet disease eradication, elimination, and control targets.
• Support evidence-based healthcare delivery models and engage stakeholders across public health and healthcare systems to increase the use of safe and effective interventions, treatments, and therapeutics through education, outreach, diagnostic and antibiotic stewardship, and other approaches in diverse patient populations, including tribal and territorial communities.
• Leverage partnerships and communication networks throughout state, tribal, local, and territorial communities to promote appropriate use of antimicrobials and antimicrobial stewardship across all healthcare and veterinary settings.
• Foster and leverage partnerships with key stakeholders throughout the food production, manufacturing, storage, and distribution enterprise, as well as tribal and Urban Indian Organization partners, to promote and implement science-based preventive control standards for contamination of domestic and imported foods.

Invest in innovative technology and development to ensure supply and availability of safe and effective diagnostics, treatments, therapeutics, medical products and devices, and vaccines

• Support the development of new, safe, and effective medical products with improved delivery characteristics, such as easier storage conditions, longer shelf-life, and reduced dosing, for the treatment, prevention, and diagnosis of non-communicable and infectious diseases.
• Support the application and use of innovative technologies, including mobilizing industry to advance manufacturing (including flexible on demand and point-of-care manufacturing) and artificial intelligence to accelerate research and manufacturing, to improve quality, address shortages, and speed time-to-market for new diagnostics, treatments, therapeutics, medical products, and vaccines.
• Advance the research and development of accessible, point of care diagnostic testing to detect non-communicable and infectious diseases to ensure that timely, safe, and effective treatments and therapeutics can be delivered equitably to all communities when needed, including underserved communities, tribes, and territories.

Leverage resources and collaborations to support and apply research, evaluation, and data insights about non-communicable and infectious disease

• Engage in research to better understand the overall disease burden and effective strategies for intervention and improved quality of life associated with chronic conditions.
• Build and maintain partnerships, including federal, non-federal, academic and industry partnerships, to promote the development, implementation, evaluation, and availability of vaccines and other treatments to combat antimicrobial resistance and microbial threats.
• Invest in data analysis, research, and evaluation efforts, including opportunities for data sharing and linkages, to better understand the burden of disease in a variety of industry and occupation settings and further the development and implementation of vaccines for high-burden diseases and diseases with epidemic or pandemic potential.
• Support the availability and evaluate the effectiveness of prevention and mitigation measures—including engineering controls, administrative controls, and personal protective equipment—in workplaces across all industry sectors, including those with social, economic, and/or environmental disadvantages that elevate risk and exposure.
• Conduct vaccine safety monitoring and clinical research to keep vaccines safe and provide compensation to people who have been injured by specific vaccines.
• Improve the ability to monitor supply chain shortages and proactively prevent them by improved transparency and data sharing among state, local, tribal, and territorial governments, industry, and federal partners—ensuring supplies are distributed on a priority basis.

Performance Goals

The HHS Annual Performance Plan provides information on the Department’s measures of progress towards achieving the goals and objectives described in the HHS Strategic Plan for FY 2022–2026.  Below are the related performance measures for this Objective.

• Increase the percentage of adults aged 18 years and older who are vaccinated annually against seasonal influenza
• Percentage of Ryan White HIV/AIDS Program clients receiving HIV medical care and at least one viral load test who are virally suppressed
• Continue advanced research and development initiatives for more effective influenza vaccines and the development of safe and broad-spectrum therapeutics for use in seriously ill and/or hospitalized patients, including pediatric patients
• Influenza vaccination rates among adult American Indian and Alaska Native patients 18 years and older

Learn More About HHS Work in this Objective

• 2021–2025 NIH Strategic Plan for HIV and HIV-Related Research: The plan provides a roadmap for the NIH HIV/AIDS research program, ensuring that funds are allocated in accordance with established NIH scientific research priorities.
• Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV): NIH has established and led the new public-private partnership, the ACTIV partnership, to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines.
• ASPR Program Office for Innovation and Industrial Base Expansion (IBx): The ASPR Program Office for Innovation and Industrial Base Expansion (IBx) is strengthening and expanding the U.S. public health industrial base and delivering innovative solutions to counter health security threats.
• BARDA COVID-19 Response: To see what BARDA has been doing to advance countermeasure development for the COVID-19 response go to medicalcountermeasures.gov
• BARDA COVID-19 Response Timeline: Explore BARDA’s efforts to make safe and effective medical countermeasures available rapidly to combat the COVID-19 pandemic.  From our early investments to build a robust and diverse portfolio to our support of the manufacturing of diagnostics, therapeutics and vaccines, this timeline provides a glimpse at the work BARDA scientists do each day with the goal of saving lives, and protecting Americans from COVID-19.
• CDC Total Worker Health Program: Advances policies, programs, and practices that integrate protection from work-related safety and health hazards with promotion of injury and illness-prevention efforts to advance worker well-being.
• Combating Antimicrobial Resistant Bacteria Accelerator (CARB-X): This public-private partnership between BARDA, NIH and Boston University is addressing the public health concern of antimicrobial resistant pathogens by supporting early development of novel and non-traditional antimicrobial products.
• COVID-19 Antiviral Development Strategy/Antiviral Program for Pandemics: Through collaboration within HHS, NIH (including NIAID) is working with BARDA on the Antiviral Program for Pandemics, launched June 2021, to respond to the urgent need for antivirals to treat COVID-19 by spurring the availability of medicines to prevent serious illness and save lives.
• COVID-19 mRNA Vaccines: Decades of NIH-supported research have revolutionized the science behind vaccine development, leading to the first two vaccines for COVID-19, which use mRNA to train the body to recognize SARS-CoV-2, the virus that causes COVID-19.
• Cyclospora Prevention, Response and Research Action Plan: The action plan outlines FDA’s strategy for reducing the public health burden of foodborne cyclosporiasis illnesses in the United States caused by Cyclospora cayetanensis in both domestically grown and imported fresh produce.
• FDA Office of Global Policy and Strategy (OGPS) Strategic Plan Fiscal Years 2020-2024: Outlines the priorities and goals for our organization, which was established in March 2019.  The final OGPS Strategic Plan identifies four complementary and connected strategic priority areas for our office: Organizational Excellence, Policy Coherence, Global Partnerships, and Information Collection and Dissemination.
• Food Safety Modernization Act (FSMA) Implementation: FDA has finalized seven major rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different points in the global supply chain for both human and animal food.
• National HIV/AIDS Strategy for the United States 2022–2025: The National HIV/AIDS Strategy, the nation's third national HIV strategy, sets forth bold targets for ending the HIV epidemic in the United States by 2030, including a 75 percent reduction in new HIV infections by 2025 and a 90 percent reduction by 2030.
• Leafy Greens STEC Action Plan: The action plan outlines the actions that are ongoing and new in 2021 to advance our work in three priority areas: prevention, response and addressing knowledge gaps.
• LymeX Innovation Accelerator: LymeX will accelerate Lyme Innovation progress and strategically advance tick-borne-disease solutions in direct collaboration with Lyme patients, patient advocates, and diverse stakeholders across academia, nonprofits, industry, and government.
• Mind Your Risks® Public Health Campaign: NIH’s Mind Your Risks® is a public health campaign that educates people with, or at risk of, high blood pressure about the importance of taking charge of their health.  Controlling high blood pressure can help reduce the risk of having a stroke and developing dementia later in life.
• New Era of Smarter Food Safety: The New Era of Smarter Food Safety represents a new approach to food safety, leveraging technology and other tools to create a safer and more digital, traceable food system.
• NIAID Universal Influenza Vaccine Strategic Plan: NIAID's Universal Influenza Vaccine Strategic Plan outlines the institute’s research priorities, focusing on research areas that will simultaneously broaden knowledge around basic influenza immunity and advance translational research efforts to drive universal influenza vaccine development.
• NIH-Wide Strategic Plan for COVID-19 Research, 2021: The plan outlines NIH’s plans to address the most recent challenges of COVID-19, such as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), or Long COVID, and SARS-CoV-2 variants.
• NIH Strategic Plan for Tickborne Disease Research: Tickborne disease is increasing in the United States and is expected to continue to grow as tick species expand their geographical reach and new tick-transmitted viruses, bacteria and parasites emerge.  The NIH Strategic Plan for Tickborne Disease Research details five scientific priorities for advancing research and development in this area.
• NIH Worker Training Program (WTP) Infectious Disease Training Program: This program supports the development and implementation of occupational safety and health and infection control training programs for workers in healthcare and non-healthcare settings who may be at risk for exposure to infectious diseases.  Created resources are aimed at protecting the health and safety of individuals who work in industries with the potential for exposure to infectious diseases.
• NIOSH Surveillance Program: The NIOSH Surveillance Program improves worker safety and health by identifying and tracking workplace injuries, illnesses, hazards, deaths, and exposures in the United States.
• Pathways to Prevention (P2P) Program: The P2P Program workshops use an unbiased, evidence-based process to identify research gaps in a scientific area of broad public health importance.  Each workshop focuses on a disease prevention topic with limited or underdeveloped research and a need for a critical assessment of the evidence.  The P2P program brings together federal agencies, researchers, and community members to synthesize the evidence and better understand the current state of the science, identify methodological and scientific weaknesses and gaps and suggest a research agenda and develop an action plan to move the field forward.
• Rapid Acceleration of Diagnostics (RADx^SM): In 2020, NIH launched RADx to support the rapid development, validation, commercialization and scale-up manufacturing of COVID-19 diagnostics and other tools for pandemic preparedness and surveillance.
• Researching COVID to enhance Recovery (RECOVER): In 2021, NIH launched The Researching COVID to enhance Recovery (RECOVER) initiative.  RECOVER seeks to understand, prevent, and treat the post-acute sequalae of SARS-CoV-2 infection (PASC), including Long COVID.
• Ryan White HIV/AIDS Program: The Ryan White HIV/AIDS Program provides a comprehensive system of HIV primary medical care, essential support services, and medications for low-income people with HIV.  The program funds grants to states, cities, counties, and local community-based organizations to provide care and treatment services to people with HIV to improve health outcomes and reduce HIV transmission among hard-to-reach populations.  More than half of people with diagnosed HIV in the United States receive services through the Ryan White HIV/AIDS Program each year.
• Sexually Transmitted Infections National Strategic Plan for the United States 2021–2025: This inaugural STI National Strategic Plan (STI Plan) sets forth a vision for the nation with goals, objectives, and strategies to meaningfully prevent and control STIs in the United States.
• Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019–2023: FDA CVM has developed a multipronged strategy designed to limit or reverse resistance arising from the use of antibiotics in food-producing animals, while continuing to ensure the availability of safe and effective antibiotics for use in animals and humans.
• U.S. Action to Combat Antibiotic Resistance: Antibiotic resistance is a national priority, and the U.S. government has taken ambitious steps to fight this threat.
• U.S. President's Emergency Plan for AIDS Relief (PEPFAR): Through PEPFAR, the U.S. government has invested over $85 billion in the global HIV/AIDS response, the largest commitment by any nation to address a single disease in history, saving over 20 million lives, preventing millions of HIV infections, and accelerating progress toward controlling the global HIV/AIDS epidemic in more than 50 countries.
• Vaccine Adverse Event Reporting System (VAERS): FDA is using the VAERS to monitor the occurrence of adverse events reported by health providers, consumers and manufacturers.
• Vaccines National Strategic Plan 2021–2025: The Vaccine Plan sets forth a clear vision for how the United States will be a place where vaccine-preventable diseases are eliminated through safe and effective vaccination across the lifespan.
• Viral Hepatitis National Strategic Plan: A Roadmap to Elimination for the United States 2021–2025: The plan provides a framework to eliminate viral hepatitis as a public health threat in the United States.